FDA Orange Book
Generic for Tavist
Tavist contains clemastine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tavist is clemastine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Tavist products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | EQ 0.5MG BASE/5ML | Discontinued | None | 2 | AA |
| tablet, oral | 2.68MG | Discontinued | None | 1 | None |
NDA 018675, 017661, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clemastine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GENUS LIFESCIENCES INC | 073283 | None (No TE code listed) | January 31, 1992 | 2.68MG |
| GENUS LIFESCIENCES INC | 073399 | AA (A-rated, therapeutically equivalent) | June 30, 1994 | EQ 0.5MG BASE/5ML |
| GENUS LIFE SCIENCES INC | 074884 | AA (A-rated, therapeutically equivalent) | December 17, 1997 | EQ 0.5MG BASE/5ML |
Questions
Is there a generic for Tavist?
Yes. The generic name for Tavist is clemastine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Tavist?
The active ingredient in Tavist is clemastine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.